Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)

K210360 · Osteonic Co., Ltd. · GWO · Jan 27, 2022 · Neurology

Device Facts

• Record ID: K210360
• Device Name: Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
• Applicant: Osteonic Co., Ltd.
• Product Code: GWO · Neurology
• Decision Date: Jan 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

Device Story

Neuro Plating System consists of titanium plates and screws used for fixation, alignment, and stabilization of cranial fractures and reconstructive procedures. Plates (0.3mm-0.6mm thick) are made of commercially pure titanium (ASTM F67); screws (0.8mm-1.95mm diameter) are made of Ti-6Al-4V ELI titanium alloy (ASTM F136). Both components are anodized. The system is used by surgeons in clinical settings. Plates are placed over fractured bone and secured with screws inserted through plate holes. Plates may be bent or cut intraoperatively to match patient anatomy. The device is provided either non-sterile (requiring steam sterilization before use) or as a sterile kit (gamma-sterilized). The system provides rigid fixation to aid bone healing and structural reconstruction.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included 4-point bending, torsion, and axial pullout strength tests. Packaging and sterilization validation (gamma) were performed for the sterile kit configuration. Biocompatibility is supported by data from the primary predicate (K190811).

Technological Characteristics

Plates: Commercially pure titanium (ASTM F67), anodized. Screws: Ti-6Al-4V ELI titanium alloy (ASTM F136), anodized. Plate thickness: 0.3-0.6mm. Screw diameter: 0.8-1.95mm. Sterilization: Steam (non-sterile kit) or Gamma irradiation (sterile kit). Single-use only.

Indications for Use

Indicated for patients requiring fixation, alignment, and stabilization of fractures in the cranial skeleton during cranial surgery and reconstructive procedures.

Regulatory Classification

Identification

A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Predicate Devices

• Neuro Plating System (K190811)

Reference Devices

• Stryker Universal Neuro 3 System (K131775)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Osteonic Co., Ltd % Sanglok Lee Manager Wise Company Inc. #507, #508, 166 Gasan digital 2-ro, Geumcheon-gu Seoul, 08507 Korea. South

## Re: K210360

Trade/Device Name: Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)

Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: December 9, 2021 Received: December 17, 2021

Dear Sanglok Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Adam Pierce Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K210360

Device Name Neuro Plating System

Indications for Use (Describe)

Neuro Plating System is intended for use in selective trauma of the cranial surgery and reconstructive procedure.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

## Date: November 9, 2021

#### Applicant / Submitter: 1.

Osteonic Co., Ltd. 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1005Ho, 1201Ho, 1202Ho, 1206Ho 38, Digital-ro 29-gil, Guro-gu, Seoul, Korea (Postcode 08381) Tel : [phone] Fax : [phone]

#### 2. Submission Correspondent

Na Young, Kang 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1005Ho, 1201Ho, 1202Ho, 1206Ho 38, Digital-ro 29-gil, Guro-gu, Seoul, Korea Tel. [phone] Fax. [phone] Email: [e-mail]

#### 3. Device:

- Proprietary Name Neuro Plating System
- Common Name Neuro Plating System
- Classification Name Preformed Alterable Cranioplasty Plate; Burr hole cover; Cranioplasty plate fastener

#### 4. Predicate devices:

- Primary Predicate devices: K190811- Neuro Plating System by Osteonic Co., Ltd. .
#### 5. Product Code & Regulation Number:

GWO, GXR, HBW (21CFR§882.5320, 21CFR§882.5250, 21CFR§882.5360)

#### 6. Device Description:

The Neuro Plating System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.95mm in lengths of 3.0 to 6.0mm. It is made of Ti-6Al-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.

Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The plate is placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient.

The Neuro Plating System has two types of sterilization method; Neuro Plating System is non-sterile state packed in PE bag which must be sterilized before use and Neuro Plating System - Sterile Kit is provide sterile state with gamma sterilization packed in Tyvek and PET. Both are single use only.

{4}------------------------------------------------

#### 7. Indication for use:

Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

#### 8. Non-clinical tests:

There are a number of differences between the predicate devices and the subject devices as presented in this submission, however, the differences were evaluated through design control, risk analysis and verification & validation activities, and test results demonstrated that the subject devices and predicate devices are substantially equivalent.

The following tests were performed:

▪4 Point Bending Test

▪Torsion Test & Axial Pullout Strength Test

▪Packaging Process Validation Test (only Neuro Plating System - Sterile Kit)

▪Gamma Sterilization Validation (only Neuro Plating System - Sterile Kit)

▪Shelf life (only Neuro Plating System - Sterile Kit)

The subject device's titanium grade is the same as the predicate device's, but the subject device is thicker than the predicate device. Therefore, the performance testing of the subject device is expected to be substantially equivalent to the predicate device.

Validation of sterilization parameters and biocompatibility of the subject device are supported by sterilization validation and biocompatibility testing as provided in the primary predicate K190811.

#### 9. Substantial Equivalence:

The subject device is similar to the predicate devices in terms of indications, materials, use and design. All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices. There might be slight differences in dimensions, shapes between the subject device and each predicate device, however, the information and the data of non-clinical testing such as mechanical testing and sterilization testing provided in this submission supports substantial equivalence to the predicate devices in safety and performance.

{5}------------------------------------------------

| | Subject device | Predicate Device | Reference Device | Equivalence |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | OSTEONIC Co., Ltd. | OSTEONIC Co., Ltd. | Stryker | - |
| Device Name | NEURO PLATING SYSTEM | NEURO PLATING SYSTEM | Stryker Universal Neuro 3 System | - |
| 510(K) # | K210360 | K190811 | K131775 | - |
| Class | 2 | 2 | 2 | Equivalent |
| Product Code | GWO, GXR, HBW | GWO, GXR, HBW | GWO, GXR, HBW | Equivalent |
| Intended Use | Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure. | Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure. | The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher). | Equivalent |
| Material<br>(Chemical<br>composition) | •Plate- Pure Titanium ASTM F67<br>•Screw- Titanium Alloy ASTM F136 | •Plate- Pure Titanium ASTM F67<br>•Screw- Titanium Alloy ASTM F136 | •Plate- Pure Titanium ASTM F67<br>•Screw- Titanium Alloy ASTM F136 | Equivalent |
| Surface<br>Treatment | • Plate: Anodizing<br>• Screw: Anodizing | • Plate: Anodizing<br>• Screw: Anodizing | • Plate: Anodizing<br>• Screw: Anodizing | Equivalent |
| Shape and<br>Dimension | Straight, angle, Y-shape, X-shape, D-Y shape, burr hole, square, matrix and mesh plate with various lengths and thickness (0.1 to 0.6mm). The screws range in diameters of 0.8 to 1.95mm and lengths from 3.0 to 6.0mm. | Straight, angle, Y-shape, X-shape, D-Y shape, burr hole, square, matrix and mesh plate with various lengths and thickness (0.1 to 0.6mm). The screws range in diameters of 0.8 to 1.95mm and lengths from 3.0 to 6.0mm. | Performed alterable cranioplasty plate, burr hole cover, cranioplasty plate fastener. | The safety and performance of plates and screws were shown to be equivalent to predicate device. - Most of components (plates and screws) of the model added this time are the same as the predicate device except for the plate_NST306X02A. The equivalence of NST306X02A with predicate device was verified. |
| Single Use | YES | YES | YES | Equivalent |
| Sterile | Neuro Plating System:<br>Non sterile, steam<br>sterilization before use<br>Neuro Plating System<br>Sterile Kit : sterile,<br>gamma irradiation | Neuro Plating System:<br>Non sterile, steam<br>sterilization before use<br>Neuro Plating System<br>Sterile Kit : sterile,<br>gamma irradiation | Sterile, gamma<br>irradiation | Equivalent |

{6}------------------------------------------------

# 10. Conclusions:

Based on documentation supplied with this submission, conclusions drawn from design control, risk analysis and verification & validation activities demonstrate that the subject devices are substantially equivalent to the predicate devices.